CONSENT FOR CDC RESEARCH

CONSENT FOR CDC RESEARCH

A Reference for Developing Consent Forms and Oral Scripts

November 1998

About the Development of this Guide

One of the more difficult tasks in developing a research study is to write a consent form thatdescribes all the information about the study in such a way that the participants can understand itand make an informed choice about whether to volunteer to participate in the study. For years,CDC investigators have been asking for guidance in writing consent forms and oral scripts.

In 1997, I asked Mr. Russ Havlak, one of the Institutional Review Board (IRB) chairs, todevelop a document for investigators to use in writing consents. Unselfishly, Russ gave his timeto produce the guide while continuing his regular job responsibilities. After much thought aboutthe best approach and what would be most useful to investigators, Russ embarked upon a long,tedious process of reviewing CDC IRB approved consent forms. He then wrote a document thatexplains the information, element by element, that should be contained in a consent form andused examples from existing approved consents as illustrations. The document he produced is,perhaps, one of the best documents available on writing consent documents and oral scripts.

We are greatly indebted to Russ for developing this reference guide for investigators. Russbegan serving on a CDC IRB in 1980 and became a chair in 1994. During that time, he has beendeeply committed to the ethical principle that potential participants should freely chose whetherto participate in research. That voluntary choice can only be made when investigators use aconsent process that fully informs participants about the research in a way that participants canunderstand the information. Russ has spent countless hours reading and editing consent formsfor all of us, in each case trying to make the consent more understandable, informative and non-coercive. This document reflects his vast knowledge and great skill in writing consent forms.

Thank you, Russ.

Marjorie A. Speers, Ph.D.Deputy Associate Director for Science

Foreword

The Centers for Disease Control and Prevention (CDC) has had an Institutional Review Board(IRB) for almost 30 years. The IRB’s role is to review proposed studies and approve those whichcomply with 45 Code of Federal Regulations, Part 46 (45 CFR Part 46), the federal regulationsthat govern research involving human participants. However, the guiding vision of the IRB hasless to do with review and approval than with the idea of helping all of CDC to carry out ethicalresearch.

The CDC IRBs have reviewed a couple of thousand study protocols over the years, giving theminsight into the strengths of CDC research and weaknesses common to the process. Top amongthe problem areas are consent documents—both written forms and oral consent scripts. Consentin human participant research should be a process that continues from the time participants signup for a study to the time they complete the study or withdraw from it. The consent form or oralconsent script is but one piece of that process, but a piece which the IRB is obligated to take veryseriously. This is a reference to help CDC investigators write research consent forms and scripts thatconform to the Federal Regulations. It draws on the wisdom gained by the IRB and offerssuggested wording similar to that found in CDC consent forms the IRB has approved. Noattributions are cited, but this does not lessen the appreciation to the many CDC investigatorswho contributed to this reference.

Table of Contents

A Note About Development of this GuideForewordTable of ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Principles and Requirements of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Basic Principles of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Required Elements of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Additional Elements of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Alteration or Waiver of Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Waiver of the Need for Signed Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

How to Make Consent Forms Easy to Read and Understand . . . . . . . . . . . . . . . . . . . . . . . . . 6Write at a Level That Matches the Reading Ability of Your Prospective Participants . . . . . . 6At Which Reading Level Should You Write Your Consent Form? . . . . . . . . . . . . . . . . . . . . 6What Tools are Available to Grade the Readability of a Consent Form? . . . . . . . . . . . . . . . . 7How To Write (or Rewrite) a Consent So That It Achieves an #8th Grade Reading Level . . . 8Tips for Eliminating Polysyllabic Words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Write to Prospective Participants--Don’t Put Words In Their Mouths . . . . . . . . . . . . . . . . . . 9Organize Your Consent Form in Sections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Three Problem Elements to Avoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

A Section-by-Section Guide to Writing Consent Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Introduction - Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Research Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Identify Sponsors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Summarize the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Explain the Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Explain Complex Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Answer the Implicit “Why me?” Question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Introduction - Less Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15CDC Not Cited in Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Blinding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Purpose of the Research - Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Purpose of the Research - Less Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Blinding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Procedures - Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Voluntary Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Randomization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Blood to be Taken and How . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Taking Other Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Procedures Not to be Done . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Questionnaires/Interviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Time Commitments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Review of Medical Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Storage Without Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Procedures - Less Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Mail/Telephone Questionnaires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Genetic Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Focus Group Taping and Related Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Avoidance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Refusal of HIV Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Use of Placebo Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Breaking the Study Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Risks or Discomforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Rare or Nominal Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Risks From Taking Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Questionnaire/Interview Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Drug Side-Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31After-Effects from Study Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Unforeseeable Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Benefits to the Participant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33No Direct Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Confidentiality - Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Legally Unprotected Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Confidentiality- Less Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Records are Subject to Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Use of “Strictly” in Describing Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35CDC Assurance of Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Cost/Payment - Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Who Pays for Various Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Payment to Participate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Cost/Payment - Less Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Who Pays when Research Merges with Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Payment Tied to Completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39No Share in Commercial Results of Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41No Compensation Provision for Injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Right to Refuse or Withdraw - Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Refusal/Withdrawal Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Right to Refuse or Withdraw - Less Common Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Consequences of Withdrawal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Orderly Withdrawal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Withdrawal by Study Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Storage of Specimens for Future Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Components of Storage Consent for Identifiable Specimens . . . . . . . . . . . . . . . . . . . . . 44

Explicit Plans for Future Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Unclear Plans for Future Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46When Genetic Testing is Possible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

The Right to Exclude Certain Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

The Right to Refuse/Withdraw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Specifying Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Persons to Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Study Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Contact for Participant Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Contact in Case of Injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Your Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50An “I” Construct Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Construct Addressing the Prospective Participant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Signature Lines, Approval Boxes, Witness Signature Lines, Designations, and Refusals . . 51Signature Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Approval Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Witness Signature Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Refusal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Appendix A - Readability Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54SMOG Readability Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55References for Spanish Readability Formulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Fry Readability Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Appendix B - Easy-to-Read Replacements for Polysyllabic Terms . . . . . . . . . . . . . . . . . . . . . . 58

Introduction

The research we conduct at the Centers for Disease Control and Prevention (CDC) providesinformation that is vital to our mission. An integral part of this research is obtaining informedconsent of all participants, as required by 45 CFR 46, the federal regulations that govern researchinvolving human participants. Throughout this reference, 45 CFR 46 is referred to as “thefederal regulations.” This reference will provide:

C A general overview of the principles and requirements of informed consentC Tips on writing and formatting consent forms that are easy to read and understandC A section-by-section guide for crafting an effective consent form

We recognize that consent can be obtained using oral consent scripts, as well as consent forms. We have chosen to focus on consent forms because they are the format required by the FederalRegulations and the most common form of consent in CDC studies. Most of the guidanceprovided in this reference will apply both to consent forms and to oral consent scripts. However,we will discuss the differences between the two when they arise.

2Consent for CDC Research—A Reference

Principles and Requirements of Informed Consent

Research involving human participants is explained in the federal regulations. The combinationof two definitions there defines research involving human participants to be a systematicinvestigation, including research development, testing and evaluation, designed to develop orcontribute to generalizable knowledge, and which involves a living individual about whom aninvestigator conducting research obtains (1) data through interventions or interactions with theindividual or (2) identifiable private information. Perhaps the most basic ethical requirement ofthis kind of research is informed consent.

Basic Principles of Informed Consent

The federal regulations set out four overriding principles which are meant to apply to allconsents, unless there are specific exceptions made or allowed elsewhere in the regulations. These principles are:

1. Human research can proceed only with informed consent unless waived under the FederalRegulations - No investigator may involve a human being as a participant in research coveredby the federal regulations without legally effective informed consent of the participant orhis/her legally authorized representative.

2. Minimize coercion in obtaining consent - An investigator shall seek consent under conditionsthat provide the prospective participant or his/her representative sufficient opportunity toconsider whether to participate, and that minimize the possibility of coercion or undueinfluence.

3. Consent must involve understandable language - The information that is given to theprospective participant or his/her representative shall be in language the participant or therepresentative can understand.

4. Waiver of rights is prohibited in the consent process - No informed consent, whether oral orwritten, may include any exculpatory language through which the prospective participant orhis/her representative is made to waive or appear to waive any of the prospective participant’slegal rights, or made to release or appear to release the investigator, the sponsor, theinstitution, or its agents from liability for negligence.

1 Minimal risk means that the probability and magnitude of harm or discomfortanticipated in the research are not greater in and of themselves than those ordinarilyencountered in daily life or during the performance of routine physical orpsychological examinations or tests. Both factors must be considered in weighingwhether a risk is greater than “minimal risk.” In deciding if research involvesminimal risk, the IRB is expected to consider risk from study procedures in relation toall persons eligible to participate--not just from the perspective of a person in goodhealth or of someone with health problems matching circumstances of the research.


Required Elements of Informed Consent

The federal regulations list eight required elements of informed consent. These are:

1. Purpose and Procedures - You must tell a prospective participant that the study involvesresearch, explain the purpose of the study and the length of time you expect the person toparticipate, describe the procedures to be followed, and identify any experimental procedures.

2. Risks - You must describe any reasonably foreseeable risks or discomforts to the prospectiveparticipant.

3. Benefits - You must describe any benefits to the prospective participant or to others whichmay reasonably be expected from the research.

4. Alternatives - You must disclose any appropriate alternative procedures or courses oftreatment that might benefit the prospective participant.

5. Confidentiality - You must tell prospective participants whether their records will be keptconfidential and, if so, explain the level of confidentiality.

6. When There is Greater than Minimal Risk1 - You must tell prospective participants whetherthey will receive any compensation and/or medical treatments if injury occurs and, if so, whatcompensation or treatment will consist of, or where to obtain further information.

7. Persons to Contact - You must tell prospective participants whom to contact if they havequestions about the research and their rights as a study participant, and whom to contact ifthey have an injury that may be related to the research.

8. Voluntary Participation, Refusal, and Withdrawal - You must state that participation isvoluntary, that refusal to participate involves no penalty or loss of benefits to which theperson is otherwise entitled, and that the person may discontinue participation at any timewithout penalty.


Additional Elements of Consent

When appropriate, the following six additional elements of consent should be included:

1. Unforeseeable Risk - You should state that the study treatment or procedures may have risksfor the prospective participant (or to the embryo or fetus, if the participant is or may becomepregnant) that you cannot currently foresee.

2. Termination of Participation Without Consent - You should explain anticipatedcircumstances under which the investigator may terminate the participant’s furtherinvolvement without regard to the person’s consent.

3. Additional Costs - You should describe any additional costs to prospective participants thatmay result from participation in the study.

4. Consequences and Process of Withdrawal - You should explain how participants can leavethe study and what may happen if they choose to withdraw.

5. Impact of Significant New Findings - You should state that participants will be told of anysignificant new findings developed during the research which may relate to their willingnessto continue in the study.

6. Number of Participants - You should tell prospective participants the approximate number ofpersons involved in the study.

Alteration or Waiver of Consent

In some cases, the federal regulations allow an IRB to approve a consent procedure whichexcludes or alters some of the 14 required and situational elements discussed previously or callsfor a waiver of consent entirely. These situations fall into two categories.

1. Research Involving Public Service or Benefit Programsa. The research or demonstration project is to be conducted by or subject to the approval of

state or local government officials and is designed to study, evaluate, or otherwiseexamine:(1) Public benefit or service programs;(2) Procedures for obtaining benefits or services under those programs;(3) Possible changes in or alternatives to those programs or procedures; or(4) Possible changes in methods or levels of payment for benefits or services under those

programs, AND


b. The research could not practicably be carried out without the waiver or alteration.

2. Other Research (not involving public service or benefit programs)To approve an alteration or waiver of consent for research involving other than public benefitor service programs, an IRB must find and document the following:a. Minimal risk - The research involves no more than minimal risk to the participants;b. No adverse affects - The waiver or alteration will not adversely affect the rights and

welfare of the participants;c. Research not practicable otherwise - The research could not practicably be carried out

without the waiver or alteration; andd. Follow-up information available - Whenever appropriate, the participants will be given

additional pertinent information after their role in the study is over.

Waiver of the Need for Signed Informed Consent

As a rule, consent forms and oral consent statements must be signed to be legally valid. However, the federal regulations recognize that, in some situations, having a signature on recordis not in the best interest of the participant. The regulations state that an IRB may waive therequirement for a signed consent form for some or all of the prospective participants in a study ifone of the following applies:1. Consent is the only link - The only record linking the participant to the research would be the

consent document, and the principal risk would be potential harm resulting from a breach ofconfidentiality. Prospective participants must decide if they want documentation linkingthem with the research and their wish is to govern; or

2. Minimal risk and a common nonconsent procedure are involved - The research presents nomore than minimal risk of harm to participants and involves no procedures for which writtenconsent is normally required outside of the research context.

When the requirement for signed consent is waived, the IRB may require the investigator toprovide prospective participants with a written statement about the research.


How to Make Consent Forms Easy to Read and Understand

Only if participants understand what you’re telling them about the study and their participationcan they give “true informed consent.” The tips that follow will help you write consent formsthat are easy for prospective participants to read and understand.

Write at a level that matches the reading ability of your prospectiveparticipants.

We tend to assume that if our colleagues can understand what we’ve written, others can too. This assumption too often proves false. Most CDC studies target persons from economically andeducationally disadvantaged populations whose reading skills tend to be at or below the 8th gradelevel. However, most consent forms for these studies are written at or above the 12th gradereading level.

To increase the likelihood that your consent form will be understood, you should:

C decide at which reading level to write your consent formC follow the rules for writing easy-to-read materialsC test the reading level of your consent form and, if too high, make any changes needed to

lower the reading level

This section will help you complete these steps.

A. At which reading level should you write your consent form?

The National Adult Literacy Survey (NALS), conducted in 1993, found that nearly half of allAmerican adults read at very basic levels. This percentage was much higher among welfarerecipients, older adults, racial and ethnic minorities, and disadvantaged and inner-citypopulations. In addition:

h Only 21% of responders performed in the highest levels.h Most people at the lowest levels did not perceive their problem; they described themselves as

being able to read “well” or “very well.”h Adults with relatively few years of education were most likely to perform in the lower levels

than those who completed high school or received some postsecondary education.h Older adults were more likely than middle-aged or younger adults to demonstrate limited

literacy skills.


The NALS is the source of the estimate that the “average” American reads at or below the 8th grade reading level. Also, the NALS found that a significant proportion of persons fromdisadvantaged, inner city, racial/ethnic minority populations read even below that level. Inaddition, the NALS found that perhaps for reasons of either self-deception or embarrassment,those with profound reading difficulties are unlikely to admit it. Thus, an investigator cannotnecessarily rely on a prospective participant’s reaction to a consent form as signifying theachievement of “true informed consent.” It argues for making any form as readable (hence,understandable) as possible, but always making it the centerpiece of a consent “process”involving enough dialogue to ensure that the person truly understood the words in the consentdocument.

B. What tools are available to grade the readability of a consent form?

Several tools are available to help a CDC investigator determine if a consent form will bereadable by a study population. One is an electronic readability formula through Grammatik inWordPerfect versions 6.1 and above. First, if the consent form is part of the protocol, rather thanin a separate document, copy the consent to a new blank document. Go into Tools and selectGrammatik. From the dialogue box, select View, and under that, Statistics. Then selectReadability, which is presented using the Flesch-Kincaid Readability Test. In WordPerfect 7.0,this is found under Analysis. The resulting grade is based on the number of words per sentenceand the average number of syllables per word. For persons (such as IRB members) who often donot have electronic versions of consents to test using Grammatik, two convenient manual optionsare available:

1. SMOG - which bases grade level on a scale that counts the number of $3 syllable (orpolysyllabic) words in 30 sentences, 10 each from the beginning, the middle, and the end ofthe document. Readability of a piece with less than 30 sentences is judged on the scale bytaking the average number of polysyllabic words from the sentences and multiplying thataverage by 30. SMOG is quick and easy to use. It equates well with other formulas at thehigh end of the readability scale. It only drops to the 5th grade level, and really does less wellwhen measuring a document written #8th grade level. It tends to overrate readability level atthese lower levels. The SMOG scale appears in Appendix A, along with references toformulas for testing the readability of materials written in Spanish.

2. Fry Graph Reading Level Index - which bases the grade level on a two-way graph withaverage sentences/100 words on one axis and average number of syllables/100 words on theother. Derive the averages by counting 100 words (including proper nouns,initials/acronyms, and number sets) at the front, middle, and end of the document. Thencalculate the means of the three sentence and syllable counts. The Fry Graph Reading LevelIndex involves more work than SMOG, but gets easier with practice. It is probably moresensitive than SMOG at all reading levels, but is much more sensitive on the lower end of thereadability scale. A copy of the Fry Graph, with more tips on its use, also appears inAppendix A. Jane Root, Ph.D., reading expert and Fry Graph advocate has a rule to only


Tips for eliminating polysyllabic words

1. Find a syno nym. For ex ample, rep lace “com pensate” w ith

“pay” or “re pay.”

2. Use active voice. Yo u can chang e “It is recomm ended” to

“We re comme nd.”

3. Try a combination of less complex words. Instead of

“researche rs,” try “peop le doing the stu dy.”

4. Start over. If replacing words and finding synonyms is too

much trouble, try rewriting the sentence. You may find an

easier way to sa y what you nee d to say.

5. Ask if the term can be deleted. In some cases, you may even

be able to delete a whole sentence, if the information is not

essential to inform ed conse nt.

6. Live with it. Accept that some terms just can’t be fixed. For

example , you can’t repla ce or dele te terms like “ba ndages,”

“reaction,” “p ositive,” and “negative.” H owever, re latively

few polysyllabic words will fall into this c ategory.

count once a medical/technical term with which there can be no doubt that the reader isalready familiar, e.g., “diabetes” in a study consent for diabetics. The CDC IRB has alsoadopted this rule.

C. How do you write (or rewrite) a consent so that it achieves an #8th gradereading level?

You can get to a #8th grade reading level, and maximize comprehension in your consent forms byfollowing some rules described below, combined with some creative writing and use AppendixB, a job aid that cites alternatives to complex terms that the IRB has found common to CDCconsent forms.

Rule 1 Assume that your study participants will not recognize any $3 syllable words you use.

Rule 2 Accept that some $3syllable words (e.g., propernouns such as organizations,places, diseases/organisms,and persons’ names) may beabbreviated (e.g., CDC, inthis state/city, HIV, AIDS,STDs), truncated (e.g.,Emory UniversityTransfusion Services Unit[Blood Center]) or reducedin their number of usages;but most cannot be replacedor deleted entirely, so use theminimum you need to andmove on.

Rule 3 Assume that nearly everyother $3 syllable word, otherthan proper nouns, CAN bereplaced, and that doing sowill improve readability(since at the 12th gradereading level the ratio ofthese “replaceable” words to $3 syllable proper nouns is about 8 to 1) in the usual CDCconsent form. For example, the following actual wording in a CDC consent: “Yourname and other information which could be used to identify you will be kept asconfidential as legally possible, ” upon revision was replaced with: “Your name andwhat you say to us for this study will be kept private to the extent allowed by law.” The


5 replaced $3 syllable words proved expendable as the sentence, now more readable,sends the same basic message.

Rule 5 Be less concerned with the length of the consent than its ability to be read andunderstood. Replacing single complex terms with a series of less complex ones oftenwill lengthen what might otherwise have been a short consent. Balance is important. Brevity is desired in that it encourages one to read a document that they might not if itwas longer. However, the esthetics of achieving that brevity is sometimes purchased atthe cost of informed consent.

Rule 6 In addition to minimizing the number of $3 syllable words in a consent form, itsreadability and comprehension can be improved by:a. Using the active voice - Concentrating on using the active voice can prevent

readability problems from the outset;b. Limiting use of medical/technical terms - At times their use is unavoidable, but

repetition can be limited by using abbreviations and some creative alternatives.c. Keeping your sentences short - Short sentences are more readable than long ones.

Whenever possible, break up sentences over 20 words; andd. Limiting ideas to one per sentence - Persons with weak reading skills will have more

trouble understanding complex sentences than ones which transmit only a singleidea. If you need to keep two ideas closely connected, consider using a semicolon tobreak them apart in a single longer sentence.

Write to prospective participants--don’t put words in their mouths.

We’ve all seen (and probably written) consent forms written in the first person singular, the “I”construct. These consent forms result in sentences that start out like this: “I understand that Iwill be asked...,” “I realize that I will be given...,” and “I recognize that I may be at some riskfor...” These sentences almost always contain words with three or more syllables and tend to behard to read. This sentence structure also seems to place the onus on the participants tounderstand rather than on the investigators to explain.

Writing to your prospective participants—rather than putting words in their mouths—soundsmuch more natural and results in language that is easier to read and understand. The sentences inthe previous paragraph, for example, are much easier to understand when written as follows: “We will ask you...,” “We will give you...,” and “You may be at risk for...” These sentencesmimic natural conversation and may more readily facilitate conversation between participantsand investigators, a critical step in the consent process.

You should avoid first person singular construction for other important reasons. It is a legalisticform and, therefore, can be intimidating to prospective participants. For this reason, IRB expertsand the Office for Protection from Research Risks (OPRR) view this construction as coercive,which is not allowed under the federal regulations.


Organize your consent form in sections.

The format of a consent form, as much as its content and phrasing, influences how well prospective participants understand it. The best way to organize your consent form, according tothe IRB, is to use headings to separate subject matter. In addition to increasing comprehension,this format can lessen the risk of omissions and redundancies.

Below is one suggested format, which allows you to cover all of the required and situationalelements of informed consent.

< Introduction< Purpose of the Research< Procedures< Risks or Discomforts< Benefits< Confidentiality< Cost/Payment< Compensation (if appropriate)< Right to Refuse or Withdraw< Storage of Specimens for Future Testing (if appropriate)< Alternative Treatment (if appropriate)< Persons to Contact< Your Consent(s)< Signature Lines, Approval Boxes, Witness Signature Lines, and Designations


Three Problem Elements to Avoid

Before using your consent form, edit it carefully. Or, better yet, have someone elseedit it for you. A thorough review can help you avoid three problem elements.

1. Proselytizing words and phrases

It’s tempting to try to “sell” your study to prospective participants by focusingon how great the benefits can be both to the individuals in the study and tosociety at large. But a consent form must present all information, good andbad, if true informed consent is to be obtained. Reread your consent form tomake sure that it does not understate the risks or overstate the benefits. You may want someone who is not involved in the study to read yourconsent form to make sure it presents an honest and objective picture of thestudy.

2. Adverbs and Adjectives

Minimize the use of adverbs and adjectives in consent forms. Thesemodifiers can result in unintended influence on prospective participants. One might be more willing to participate in a study with risks involved if it willlead to “vital” information about a disease or “substantially” improveunderstanding of a health issue.

3. Spelling Errors

Errors reflect poorly on the author of a document of any type. Do not rely onyour word processor’s spell check. You still need to reread your consentform carefully to eliminate spelling errors. For example, your word processorwon’t know that “you” is supposed to be “your” or that “them” should be“then.” Manually proofread your consent form after having applied anelectronic spell check. Also, an editor can proofread your consent formquickly to find errors like these.

Note: The principles and rules discussed in this section also apply to writing an oralconsent script.


A Section-by-Section Guide to Writing Consent Forms

This guide will walk you through the process of writing a consent form, section-by-section. Itaddresses the common situations you will face in conducting research at CDC, as well as someless common situations. Throughout the guide, you will see examples of wording similar to thatwhich the IRB has approved in CDC consent forms. These examples appear in “bolded italics inquotation marks.”


INTRODUCTIONCommon Situations

INTRODUCTIONResearch Purpose

INTRODUCTION Identify Sponsors

INTRODUCTIONSummarize the Problem

INTRODUCTION - Common Consent SituationsEach consent form should begin with a clearly labeledintroduction that does the following:

1. Clarify the Research Purpose - You want prospectiveparticipants to know that they are giving their consent totake part in research and not agreeing to let you perform amedical procedure, get medical records, or some otherroutine purposes. If the project name you cite in theIntroduction section does not convey this idea, use asimple declarative sentence. For example,

“This project we want you join is a research study.”

2. Identify the Study Sponsors - Identify all of the agencies,organizations, and institutions that are asking theprospective participant to take part in this research so thatthe participant knows who is responsible for what theparticipant is being asked to do. This will likely requirethe use of several polysyllabic words—mainly propernouns and medical/technical terms. To improve thereadability of your consent form, you want to giveabbreviations and simplified terms now so participants willrecognize them later in the form. For example,

“The Tropical Disease Research Centre and theCenters for Disease Control and Prevention (CDC)in Atlanta, Georgia, USA, are doing a study onmalaria.”

3. Summarize the Problem - Summarize the (actual orpotential) illness-producing problem which is importantenough to justify both the study and the person’sparticipation. For example,

“Doctors have learned a lot about what affects thehealth of mothers and babies. But there is stillmuch that we do not know. Through this study, wehope to learn more about what causes babies to beborn premature.”

4. Explain the Disease - Most CDC studies involving human


INTRODUCTIONExplain the Disease

INTRODUCTION Explain Complex Concepts

participants are focused on a specific disease, syndrome,medical condition, or environmental risk. Prospectiveparticipants, in general, may know something about thestudy focus. However, an investigator cannot assume thatthey know enough to give their informed consent. Thechallenge is to provide an explanation in which the wordsare readable and the content can be understood. Thefollowing language, approved by the IRB, is a goodexample:

“Hepatitis B is an infection of the liver caused by thehepatitis B virus (HBV). Acute hepatitis sometimesbegins with mild feelings of illness. These mayinclude loss of wanting to eat, a feeling of illnesscoming on, and being very tired. A person alsocould have an upset stomach, vomiting, stomachpain, dark urine, and jaundice (yellow eyes andskin). At times, a skin rash and joint pain canoccur.”

5. Explain Complex Concepts - CDC studies often requirethat prospective participants understand rather complexconcepts if they are to give fully informed consent. Someof these concepts include multi-drug resistance, diseasediagnosis, and complicated testing procedures. Theexamples below are from CDC IRB-approved consentforms and do well in explaining complex issues in fairlysimple language.

“TB germs are strong and take powerful drugs tokill them. Some TB patients have mutant germswhich are “resistant” to the TB drugs. This meansthat the germs are so strong that they are not killedby some of the drugs. TB germs can becomeresistant if TB patients do not swallow their pillsevery day. TB patients who do not take the pills canspread these resistant germs to others. Those otherpeople can become sick with resistant TB. Patientswho have these resistant germs must be treated withspecial drugs to be cured.”

*****

“The long-term storage place of lead in the body is


INTRODUCTION Answer “Why me?”

in the bones. We will measure the amount of lead inyour bones and the density of your bones. This is toassess the amount of lead in the bones and if thatlead has had any effect on them. We measure bonedensity based on X-rays with low radiation doses. We will measure the minerals in the bones in aperson’s hip and spine. These measures will take us30-60 minutes of your time. We will measure theamount of lead in the bone by using a techniquecalled X-ray fluorescence. For this test, we will askyou to sit still for between 15-30 minutes.”

6. Answer the Implicit “Why Me?” Question - Explain whyprospective participants have been chosen. This reasonmay differ for study participants and control participants. Suggested readable wording akin to that which the IRB hasapproved in CDC consent forms include:

“We are asking you to be in this study because youare a resident of Goodwin House. We are askingpeople who got flu vaccine there during the past 5years and also some who did not get the vaccine.”

*****

“We are asking you to be in the study because youlive in the farming area which may have exposedyou to this chemical.”

INTRODUCTION Less Common Situations

INTRODUCTION CDC Not Cited

INTRODUCTION - Less Common SituationsThe Introduction section almost always addresses commonresearch situations. However, two other circumstancesoccasionally arise within this section which bear mentioning.

1. CDC’s Participation Should Not be Cited in the Consent -On rare occasions, usually in studies conducted outside ofthe United States, circumstances arise where it isstrategically necessary not to cite the role of CDC as asponsor or active participant in the research. The IRBunderstands that such situations can occur. However, theprocess requires the investigator to explain the backgroundand ramifications in detail as part of justifying any suchdeletion of a reference to CDC’s role.


INTRODUCTION Blinding

2. Participants Must be Blinded to Some Aspect of the StudyOn rare occasions, full knowledge of the study aspectsusually addressed in the Introduction section mightproduce either a selection bias among prospectiveparticipants or a response bias among actual participants. The IRB understands that certain types of CDCepidemiologic studies may face this potential problem. However, the IRB may alter the consent process if it cando so according to the criteria in the federal regulations(see page 7 of this reference). Therefore, if either theproblem summarization and/or “Why me?” explanationsegments of the Introduction section are points in the formwhich require blinding, the informing language should beinserted in its place. Suggested readable wording akin tothat which the IRB has approved in CDC consent formsinclude:

“We do not want to influence your (enrollment/answers) so there are some details of the study(about why we asked you to enter the study) that wecannot tell you about until the study is over. But atthe end of the study, we will send you a report of ourfindings and answer any questions you may have.”

PURPOSE OF THERESEARCH Common Situations

PURPOSE OF THE RESEARCH - Common SituationsUse the Purpose section to explain the research question to beanswered by the study. While this information could beincluded in the Introduction section, it is helpful to discuss itseparately.

We have not included any specific examples in this sectionbecause each consent form calls for unique phrasing based onthe research question associated with its protocol. However,remember that the wording in this section should be easy toread and understand; do not simply restate the researchprotocol


.

PURPOSE OF THERESEARCH Less Common Situations

PURPOSE Blinding

PURPOSE OF THE RESEARCH - Less CommonSituationsThe Purpose of the Research section almost always is astraightforward explanation of the research question. On rareoccasions, however, the circumstances of the research dictateotherwise.

Participants Must be Blinded to Some Aspect of the Study -As in the Introduction section, on rare occasions, fullknowledge of the study aspects usually addressed in thePurpose of Research section might produce either a selectionbias among prospective participants or a response bias amongactual participants. (Procedures for requesting an alteration ofinformed consent begin on page 4 of this reference.) Thewording used here is roughly identical to what is suggested forthe Introduction section on the previous page.

“Because we do not want to influence your(enrollment/ answers), there are some details of thepurpose of the study that we cannot tell you aboutuntil the study is over. But at the end of the study,we will send you a report of our findings and answerany questions you may have.”

PROCEDURES Common Situations

PROCEDURES Voluntary Participation

PROCEDURES - Common SituationsUse the Procedures section to explain the study design. Whilethis will vary from one study to another, certain proceduresare common to CDC consent forms, and all forms shouldinclude a statement that participation is voluntary.

1. Participation is Entirely Voluntary - Tell prospectiveparticipants early in the consent form that being part of thestudy is completely their decision. This message can beintroduced here, in the Refusal/Withdrawal section, or inboth places. The last choice results in some redundancy,but it is advised due to the importance of the message. Suggested readable wording akin to that which the IRBhas approved in CDC consent forms include:

“You are free to join the study or not. If you do notjoin, you will not lose any health care service thatyou expect to get apart from this study.”


PROCEDURES Randomization

PROCEDURES Blood to be Taken and How

2. Randomization - Randomization is common to CDCresearch protocols. If your study design employsrandomization, you must explain it in the consent form. Some CDC investigators have devised simplified wordingto explain this procedure. Suggested readable wordingakin to that which the IRB has approved in CDC consentforms include:

“The decision of who receives calcium and whoreceives starch is random, like the lottery. Nobody,neither you nor us, will know who is receivingwhich. This will be kept secret until the end of thestudy, when we all will know who received whichsupplement.”

*****

“If you agree to be in this study, you will be in oneof the two groups by chance.”

*****

“You have a fifty-fifty (50%) chance of being in oneof two groups.”

3. Blood to be Taken and How - Taking blood is a procedurecommon to many CDC studies. The consent form needsto explain the amount of blood to be taken, in equivalentteaspoons, tablespoons, or other measures with whichmost participants would be instantly familiar. Also, theconsent should specify how and from where the blood willbe taken. Suggested readable wording akin to that whichthe IRB has approved in CDC consent forms include:

“If you choose to be in this study, we will drawabout 30 ccs (2 to 2 ½ tablespoons) of blood fromthe vein in your arm.”

*****

“If you allow your child to be part of this study, wewill take about 1 cc (about 2 or 3 drops) of blood byusing a finger stick.”


PROCEDURES Taking Other Samples

*****

“We will collect the blood in a tube the size of aman’s finger. It holds 5 ml, or the same amount asone teaspoonful.”

4. Taking Other Samples - While taking blood is common inCDC studies, it is not the only type of specimen which isneeded for research. Examples of readable working akinto what the CDC has approved in CDC consent forms fora number of these situations include:

[Saliva Specimens]“To collect a saliva sample, we will ask you to holda small cotton pad between your cheek and lowergum for 2 minutes. This pad will have a salty taste,but does not present a risk to you.”

[Nasal Specimens]“We will obtain this sample by placing a cotton-tipped swab inside your nose. We will twirl it gently,and leave it in place for a few minutes before weremove it.”

[Nasopharyngeal Specimens]“We will collect the nose sample by very brieflyplacing a small cotton swab into your nose. We will quickly wipe a second swab across the back of yourthroat. We will test these samples to see if yourillness was caused by the flu virus.”

[Vaginal Secretion Specimens]“While you are lying down, you will place a syringefilled with a mild salt water solution in your vagina,as you would a tampon or douching syringe. Youwill squeeze out solution, and then draw it back intothe syringe. Then you will put the solution that is inthe syringe into a test tube.”

[Genital Ulcer Specimens]“If you are a man or a woman with ulcers or soresin the genital area (on, in, or near your penis orvagina) - We will take a sample of fluid aftercleaning the base of the ulcer. As a rule, this is


PROCEDURES Procedures Not to be Done

PROCEDURES Questionnaires/Interviews

painless but it may cause some slight burning. Wewill send this sample out of the country for testing. Thus, it will not be available for deciding on thetreatment of your ulcer or sore.”

5. Procedures Not to be Done - In some cases, it is asimportant to cite the procedures which are not involved asto cite those which are important. An example of readablewording addressing such an issue akin to that which theIRB has approved includes:

“Your doctor or nurse practitioner will take asample from your cervix (the opening of yourwomb). They will take two swabs (like a Q-tip) forthis study during your routine scheduled internalexam. No internal exams will be performed just forthis study. We are asking you to be in this studybecause you are going to have an internal examanyway.”

6. Questionnaires/Interviews - Administering questionnairesand conducting structured interviews have always beencommon components of CDC research. In your consentform, find a more readable synonym for the wordsquestionnaire and interview (e.g., “survey”), if possible. Then explain how much time is required, the nature of thequestions (noting any sensitive areas of questioning), andthe fact that the participant is not required to answer anyof them, for any reason. A common error to avoid iscombining the statement that some questions may besensitive with the fact that participants may choose not toanswer any question. This can seem to put a condition ondeclining to answer (e.g., feeling embarrassed, feeling it istoo sensitive, etc.). You want participants to know thatthey can decline to answer any question, for any reason,without feeling a need to justify their reason. Suggestedreadable wording akin to that which the IRB has approvedin CDC consent forms include:

“We will ask you to take part in a survey in whichwe will ask you a number of questions. This surveywill take about ½ hour. During this survey, we willask you questions about the health care you gotwhen you were last pregnant and about having HIV.


PROCEDURES Time Commitments

PROCEDURES Review of Medical Records

PROCEDURES

Some of these questions ask about your sex life andmay concern you. You may choose not to answerany question and for any reason. Say that you wantto pass on the question and we will just move on tothe next one.”

*****

“...It’s all right to skip any question you don’t wantto answer. You may end the questions any time youwant. This won’t affect any care that you or yourchild expect to get at the clinic or from your doctor.”

7. Time Commitments - It is important to tell prospective

participants how much time their enrollment will entail. This can be done procedure by procedure, as above, or insummary fashion. Suggested readable wording akin tothat which the IRB has approved in CDC consent formsinclude:

“We will need less than 5 minutes to take the bloodsample. The interview will take about 30 minutes,and the other tests should be over in 1½ hours.”

8. Consent for Review of Medical Records - Often the studydesign of a CDC protocol will call for a review andabstraction of a participant’s medical records. TheProcedures section is where this is explained. Suggestedreadable wording akin to that which the IRB has approvedin CDC consent forms includes:

“We need to check with doctors who have givenyour child health care. They need to confirm thatyour shot record shows all of the vaccines s/he hasgotten and that we haven’t missed any. To let us dothis, we ask you to sign a form to let those doctorsshare your records with us.”

9. Storage Without Identifiers - The Procedures sectionshould be used to announce plans to store leftovers ofblood or other specimens for future testing when thespecimens will be stored WITHOUT identifiers. (Aseparate section is needed when specimens are to be storedWITH identifiers—see page 44 of this reference


Note: The last sentence of this example is very important. You must letprospective participants know that they do not have to let you store theirblood or other specimens—it’s their choice.

Storage Without Identifiers

PROCEDURES Less Common Situations

PROCEDURES Mail/TelephoneQuestionnaires

document.) Meanwhile, suggested readable wording akinto that which the IRB has approved in CDC consent formsfor announcing the intent to store specimens withoutidentifiers includes:

“We would like to store any blood that is left overafter we do your test. We plan to use this sample forstudies we will do in the future. We will store yoursample with some data about you, such as your age,race, sex, and about your heath problem. But wewill not put your name on the sample, and there willbe no way to know it is yours. Thus, we will not beable to report back any test results to you. You candecline to let us store your blood and still be in thisstudy.”

PROCEDURES - Less Common SituationsOccasionally, CDC protocols involve the use of mail andtelephone questionnaires, focus groups, placebos, or situationsin which it may be necessary to break the study code. Becausethese situations can be inherently more sensitive than some ofthe common situations, you must explain them in wordsprospective participants can understand.

1. Mail and Telephone Questionnaires - Interviews andquestionnaires are common procedures in CDC studies,and sometimes they are administered by mail or over thephone. These involve the same elements of informedconsent that apply when such instruments are administeredin person, plus some special elements: assertive impliedconsent (through the return of a questionnaire), a reminderof the right of refusal to answer questions, and anexplanation of the procedure to account for responses. Examples of readable wording akin to that which the IRBhas approved for CDC consents include:

[Assertive Implied Consent]“We will take your return of the completed survey asyour consent to be part of this study.”


PROCEDURES Genetic Testing

[Right of Refusal to Answer Questions]“It would be helpful to have a complete response. But, you are free to choose not to respond to anypart of the survey. We will not contact you furtherabout any questions which you decline to answer.”

[Explaining Response Accounting]“You will see that your survey does not ask yourname or for any other way to identify you. But, youwill see that it is stamped with a number. Thatnumber matches to your identity on a list. We willkeep that list only to track who has and has notresponded. We expect to follow up with those whohave not sent us a response. After we haveperformed our follow-up, we will destroy the list. This will break any link to the names of personswho completed the survey.”

2. Genetic Testing - While genetic testing has not beencommon in studies thus far, genetic testing technology andits potential applications are growing. The process spans awide spectrum of biomedical applications, includingtesting the DNA of infecting organisms; identifying thegenetic predisposition of participants and their families tolife-threatening, untreatable, hereditary conditions; andpinpointing potential cures for diseases and illnesses. Ifyour study will involve genetic testing, you mustthoroughly explain it in your consent form. Examples ofreadable wording describing genetic testing akin to thatwhich the IRB has approved in CDC consents include:

“The only genetic testing we will do on your blood isto help us learn more about the disease. It may helpus develop better tests for schistosomiasis.”

*****“We will test part of this blood sample to study yourchild’s DNA and the folic acid and homocysteinecontent of his/her blood. Tests will be done onsamples with names removed. There will be no wayto link a sample to your child. This means that forthis study, we cannot give you back any test results.”

*****


PROCEDURES Focus Group Taping, etc.

“We would like to test your blood to learn yourhuman leukocyte antigen, or HLA type. Your HLAtype is a basic genetic marker that helps the bodyrecognize itself. For instance, HLA markers helpyour body detect and fight cells that are infected orabnormal (such as cells infected with a virus). Andthese markers avoid other healthy cells in the body. We will use this to learn if a certain HLA type isassociated with certain immune responses tomeasles.”

3. Focus group taping and related issues - The use of focusgroups is becoming much more common. The proceduralrequirements to carry out an effective focus group session(e.g., to transcribe responses and/or to video/audio tape theinteraction) raise some special concerns. These includehow participants are identified in the focus group session,how the session will be observed and recorded, andconfidentiality issues related to any recordings. Theseconcerns need to be addressed in the protocol, but shouldalso be explained in the consent form. Suggested readablewording akin to that which the IRB has approved in CDCconsent forms includes:

“For the focus group, we will ask you to pick aname other than your own to call you by. We willgive you a tag with that name on it. You can expectthat some study staff will sit in and take notesduring your focus group session. Also, we plan torecord the session on audio tape. Only study staffwill be able to use the tapes. The tapes are to helplearn more about what is said by all of you as youdiscuss the topics. At the end of the study, we willerase the tapes and throw them away.”

4. Avoidance Requirements - On occasion, participation in aCDC research project may mean suspending certainfunctions required for study testing procedures, avoidingcertain drugs which could confound research results, ordiscontinuing certain lifestyle practices. Prospectiveparticipants need to know about these requirements inorder to give their informed consent. Suggested readablewording akin to that which the IRB has approved to


PROCEDURES Avoidance Requirements

address this contingency in CDC consent forms include:

“During this study, we ask that you not take anyantimalarials other than what the team gives you.”

*****

“Rifampin may interfere with other drugs you maybe taking. We will discuss your list of drugs, then tell you of possible problems with any of them.”

*****

“We ask people in the study not to receive any othervaccine. This applies to the 2 weeks before and the2 weeks after each meningococcal serogroup Bimmunization. If you need to receive any otherimmunization during the study period, please tell amember of the study staff listed above.”

*****

“Between the visit today and the one next week, weask that you not have sex. If you feel that youcannot do this, we ask that you use a condom whenyou do have sex.”

*****

“You must not eat or drink anything (other thanwater) from after dinner until the morning of thetest. At that time, we will give you a sweet coladrink. One test will be done before you drink thecola and the other one 2 hours after drinking thecola.”

*****“If you join the study, we will ask that you not eatanything for 4 hours before the test. In the test, youwill drink a can of orange juice, and then breathedown a straw into a tube. This provides a baselinebreath sample. You will then drink a test solution;30 minutes later you will again breathe down astraw into a tube. This is the test sample.”


PROCEDURES Refusal of HIV Test Results

5. Refusal of HIV Test Results - CDC studies involvingserologic testing for HIV antibody remain fairly common. However, the issue of whether participants should be ableto refuse to get their test results is fading into obscurity. This is true at least in developing countries where antiviraltherapies are making the knowledge of one’s HIVantibody status a life preserving necessity. However, insome domestic research situations, and in developingcountries, this issue remains alive. Policy of theDepartment of Health and Human Services (HHS)developed in 1988 remains in effect on this issue. Insummary, it says that, in domestic research, individualswhose HIV test results are associated with personalidentifiers MUST be informed of their results andprovided with the opportunity to receive appropriatecounseling; they may not be given the option not to know,either at the time they consent to the test or thereafter,unless an exception is granted.

An exception to the HHS policy may be considered forstudies in foreign sites. However, allowing a right torefuse must be consistent with host country cultural normsand the resources, capabilities, and official health policythere. Also, the IRB must determine that the modificationof policy to allow refusal is significantly justified by therisk/benefit evaluation of the research project itself. Sincethe default is to not allow a “right to refuse HIV tests”,suggested readable wording akin to that which the IRB hasapproved in CDC consent forms include:

“If you choose to be in this study, we will take yourblood and test it for HIV antibody at CDC. We willgive you the results of that test. We will also explainthe results. We will counsel you about what youmight do next and services open to you.”

6. The Use of Placebo Controls - When you conduct aplacebo controlled trial, your consent form must explainwhat this is, why it is used, and how it will work. Suggested readable wording akin to that which the IRBhas approved in CDC consent forms includes:

“In this study your child will be put in one of two


PROCEDURES Use of Placebo Controls

PROCEDURES Breaking the Code

groups as a matter of chance. Children in onegroup will get the drug we want to test. The othergroup will get pills which look the same, but theywill have no drug in them. They are harmless andare meant to hide who has the drug. This is so ourstudy doctors will give each child the same examand not look harder at one group over the other. This will give the drug the fairest test and allow usto tell if it works.”

*****

“We are doing this study to see if giving this druglate in pregnancy will also lower the chance of amother passing the virus to her baby. To do this, wewill give some women the drug and give otherwomen a placebo. A placebo is like a “sugar pill”which has no benefit or risk to your baby’s health.”

7. Conditions for Breaking the Study Code - In blindedrandomized clinical trials, and occasionally in other typesof CDC studies, there is a real prospect of breaking thecode before the study ends. Prospective participants needto hear about this possibility so that they understand theoperating rules, and are not surprised if it occurs. Samplewording might pick up from the example cited just aboveand add:

“...to tell if it works. Before the study ends, ourexams may tell that many children are getting illwhile others are staying well. In that case, we maylook at the code that tells us which children are ineach group. If this tells us that the drug is working,we will end the study early and give the drug toevery child.”

RISKS OR DISCOMFORTSNaturally, risks or discomforts are going to vary in type anddegree from one study to another. The charge is to neitherunderstate nor overstate risks so that a prospective participantwill be able to make an informed choice about entering thestudy. The challenge is to explain those risks in a way thatprospective participants can understand. The more commonrisk situations that find their way into CDC consent forms are


RISKS/DISCOMFORTS

RISKS/DISCOMFORTS Rare or Nominal Risks

RISKS/DISCOMFORTS Risks from Taking Blood

addressed below. These begin with a common situationwhere the risk is minimal.

1. Rare or Nominal Risks - Even when risks or discomfortsare rare or minimal, you should discuss them in yourconsent. Examples of readable wording akin to that whichthe IRB has approved for CDC consent forms include:

“We expect the risks to you for being in this study tobe rare, but we cannot rule them out. For instance,it may be hard to talk to your sex partner(s) aboutyour infection. But you should try to do this even ifyou don’t want to be in this study.”

*****

“All the steps to be carried out by this study havebeen approved from a child safety standpoint. Theyare widely used in America. There is a slight stingfrom the shot. For some children, there may be asmall bruise at the site of the shot that will quicklygo away.”

2. Risks from taking blood - Serologic testing is one of themost common components of CDC research protocols. Whether this is done by finger stick or taking blood from avein, the consent needs to explain the risks entailed. Readable wording akin to that which the IRB hasapproved in CDC consent forms include:

“You may feel a slight sting or “pinch” in your armwhen the blood is drawn. You may also get a smallbruise where the needle went in. Some people faint,but this is rare.”

*****

“Drawing the blood may hurt a little. Bruising,bleeding, and rarely, infection could occur wherethe needle enters your vein.”

*****

“The main risk to you in being part of this study is


RISKS/DISCOMFORTS Questionnaire/InterviewRisks

taking your blood. There is a small chance youcould get germs in the spot where the blood wastaken and it could get infected. If the area aroundthe spot gets red and sore, you would need to go tothe clinic.”

*****

“Your child will feel a slight sting (like a pin prick)when we take blood from a vein. The hurt will beover quickly. The stick we use is sterile, so it willnot harm your child. Also, the amount of blood wetake will not harm your child at all. Your child mayhave a bruise from where the needle went in, butthis will go away soon.”

3. Questionnaire/Interview Risks - Nearly all CDC researchinvolves the use of some type of questionnaire orinterview as part of their study design. Depending uponthe subject of the study, the risk may range from negligibleto substantial embarrassment, discomforts, orpsychological trauma. As stated earlier, the proceduressection should spell out the focus of these proposedinteractions and highlight the subject matter which may beproblematic for the prospective participant. In thissection, the foreseeable risks associated with thosequestionnaire/interview aspects should be detailed. Suggested readable wording akin to that which the IRBhas approved in CDC consent forms include:

“When we do the survey, none of the privatequestions we will ask you are about touchy matters. So none of them should make you uneasy. But aswe said, you can choose to not answer any of themthat you wish, for any reason.”

*****

“As we said, our survey will ask you questions abouthow you live and what you do. As part of that, wewill ask about the type of sex you have, if you’ve hadan STD, and drugs you may use. Those questionsmay trouble you to think about or answer them, orembarrass you. But as we said, you can choose not


Note: Each example above contains a reminder that the participant is free todecline to answer any item. While this repeats what is said in theProcedures section, the importance of this message warrants theredundancy.

to answer any of them that you wish-for anyreason.”

*****

“In asking about the child you just lost, we knowthat this may be hard for you to relive. You face arisk that this may depress you, perhaps a great deal. If you are not ready to be in this study, you mayneed to see a doctor after to help you cope. But as

On occasion, circumstances of the research may suggestthat the risks of answering a questionnaire/interview arebalanced by certain risks in declining to respond. Forexample,

“If you choose to answer our questions, the onlyrisk is perhaps feeling bad if you tell us about givingthe tainted vitamins to other children in the house. That was not supposed to happen, but it is OK totalk about this. In fact, it is only bad not to talkabout it because one or more children might missthe chance to get a needed test.”

4. Drug Side Effects - Most therapeutic agents that studyparticipants may be asked to take will produce side effectsto some degree. Prospective participants need to knowabout these side effects and their dimensions in order tomake an informed decision about joining the study. Whenyou know how often certain side effects occur, include thisinformation in your consent form. Suggested readablewording akin to that which the IRB has approved in CDCconsent forms include:

“Our review of response forms we got between 1992and 1994 showed that about 12% of person getting


RISKS/DISCOMFORTSDrug Side-Effects

RISKS/DISCOMFORTS After-Effects from StudyProcedures

this toxoid had side effects where they got the shot. Most often this is only redness, but it may swell upand limit your arm movement. In about 10% ofcases, the reports showed that people had moregeneral reactions. This added up to one or more ofthe following: pain and soreness; itching; feelingtired; feeling queasy or throwing up; seeing double;a prickling feeling on the face and body; or a rash. If you have any of these, report them to the studyperson whose name is on this consent form.”

5. After-Effects from Study Procedures - Some CDC studiesinvolve procedures from which participants may expect toexperience after-effects. These should be described sothat prospective participants can make an informeddecision about whether they want to incur those risks. Suggested readable wording akin to that which the IRBhas approved in CDC consent forms includes:

“The apheresis process may also cause you to feelsome effects on your health. One bad effect fordonors is that they may have a slight drop in theirred cells (anemia) or in their platelet count. Thiswill not be severe and returns to normal over time. The long term effect of the drop in lymphocytes isnot known.”

*****

“Risks of white cell donation are the same as therisks of giving blood. These include feeling queasy,throwing up, having chills, feeling light in the heador fainting. It can also involve blood loss, seizures,and infection and swelling or bleeding around theneedle site. The risk of giving white blood cells alsoincludes getting a blood infection and havingmuscle cramps. It can also involve getting atingling around the lips due to a reaction betweenACD-A (anti-coagulant) and your body’s calcium. These risks are rare and occur less than 1% of thetimes people donate. Another risk from white celldonation is getting an air embolus (a bubble of airthat travels through the blood). The risk of gettingan air embolus is very rare. It happens less than


RISKS/DISCOMFORTS Unforeseeable Risks

.0002% (less than 1 in 500,000) of the times peopledonate. An air embolus is a very rare but seriousrisk, since it could result in stroke or death.”

6. Unforeseeable Risks - When indicated by prior safetyresearch, a statement should be added that a particulartreatment or procedure may involve risks which arecurrently unforeseeable for the subject (or the embryo orfetus, if a participant is or may become pregnant).Suggested readable wording akin to that which the IRBhas approved in CDC consent forms includes:

“We do not expect any risks to you from being in thisstudy or our focus group. While our focus groupleader is very good, it is an open discussion. Issuesdiscussed could make you feel uneasy, and you couldreveal private things that you later regret.”

*****

“This vaccine has been used in other countries, but ithas not been used in the U.S. until now. This makesits use here experimental. We do not expect risks toyour child from taking this vaccine beyond those wehave already told you about. But we cannot becertain until we study the vaccine here. We will stopthe study at once if we learn of any new risks.”

BENEFITSSimilar to the Risks or Discomforts section, the Benefitssection should give a balanced explanation of benefits thatprospective participants can expect. It should also address anybenefits to others or to society at large. Citing the latter growsin importance proportionate to any decrease in direct benefitsto a person’s participation.

1. Benefits to the Participant - Sometimes, CDC studies canhave direct benefits to those who participate. Suggestedreadable wording akin to that which the IRB has approvedin CDC consent forms include:


BENEFITS

BENEFITS Benefits to the Participant

BENEFITS No Direct Benefits

“We expect that if this vaccine works, it will keepyour infant from getting the hepatitis infection.”

*****

“The benefits to you of being in the study arelearning if you have this parasite so that you can getproper care and treatment.”

*****

“The benefits of being in this study include knowingyour present health status and also knowing yourrisk of developing AIDS.”

2. No Direct Benefits - When there is no foreseeable benefitto the participant, regardless of potential benefits to others,clearly explain this fact. Suggested readable wording akinto that which the IRB has approved in CDC consent formsincludes:

“You will get no direct benefit from being a part ofthis study. But helping to carry out this research hasa chance to tell us a lot about the disease. If so, thatcould be of future benefit to you or to someone youknow.”

CONFIDENTIALITY - Common SituationsThe Confidentiality section must affirm both that studyrecords will be kept confidential (try substituting “private” asan inexact but less complex term) and physically secure fromunauthorized access. As study information increases insensitivity, the urgency to explain confidentiality and securityalso increases. Making records safer is how you can have astudy considered “minimal risk” even though the data, were itever to be released, could pose a real problem for participants.

Legally Unprotected Research - The most common situation isthat CDC research projects are conducted without specificlegal protections. For reference, the legal protection whichcould apply are sections 301(d) (Certificate of Confidentiality)


CONFIDENTIALITY Common Situations

CONFIDENTIALITY Legally UnprotectedResearch

CONFIDENTIALITY Less Common Situations

and 308(d) (CDC Assurance of Confidentiality) of the PublicHealth Service (PHS) Act. Also, a few states have stringentconfidentiality laws which apply to research involving humanparticipants. Except where these specific protections apply, itis inaccurate to use the term “strictly confidential” or itssynonyms (e.g., “totally” or “entirely” confidential) in theconsent process. That simply assures more protection than theinvestigators are able to provide, as study records indeedwould be subject to disclosure if ordered by judicial or lawenforcement authorities. Suggested readable wording akin tothat which the IRB has approved in CDC consent formsrelated to unprotected research includes:

“What we talk about and your test results will be keptprivate to the extent allowed by law. To protect yourprivacy, we will keep the records under a codenumber rather than by name. We will keep therecords in locked files and only study staff will beallowed to look at them. Your name or other factsthat might point to you will not appear when wepresent this study or publish its results.”

CONFIDENTIALITY - Less Common SituationsOn occasion, a CDC study will have its records subject toreview by regulatory authorities. Or a CDC study may befurther protected under the PHS Act. Whenever any of thesesituations apply, the Confidentiality section needs to explainthat information with identifiers will be shared with otheragencies.

1. Records are Subject to Review - On occasion, a CDCstudy will be subject to outside review. The usualexample is when the study is conducted in associationwith a blood banking facility, whose records the Food andDrug Administration may review. Suggested readablewording akin to that which the IRB has approved in CDCconsent forms for this situation includes:

“Emory Clinic will keep a private record of each timeyou donate. Only staff who are allowed will haveaccess to your records, except as the law maydemand. Also members of the Food and DrugAdministration may look over your records duringtheir required reviews.”


CONFIDENTIALITYRecords are Subject toReview

CONFIDENTIALITYAllowed Use of “Strictly” inDescribing Confidentiality

CONFIDENTIALITYCDC Assurance ofConfidentiality

2. Allowed Use of “Strictly” in Describing Confidentiality -When a CDC study is covered locally under stringent stateconfidentiality laws which protect against court-ordereddisclosure, or a federal Certificate of Confidentialityissued by CDC, which is even stricter, the consent to usethe term “strictly” in describing confidentiality (“privacy”for readability) is allowable. Suggested readable wordingakin to that which the IRB has approved in CDC consentforms related to such protected research includes:

“Your records in this study are strictly private. Noone other than study staff can ever look at themunless you agree to it. This is because the study hasbeen granted a Certificate of Confidentiality under afederal law [Section 301(d) of the Public HealthService Act]. This means that the records of thisstudy may not even be called into federal, state, orlocal court without your OK. That applies forever.”

2. CDC Assurance of Confidentiality - Some CDC researchprojects are granted an Assurance of Confidentiality underSection 308(d) of the PHS Act. An Assurance ofConfidentiality also offers stringent protection for studyrecords, denying disclosure from court order or otheraccess. However, it is important to understand that anAssurance only protects study records held at CDC and byits contractors. If the study is conducted through localsites and study records are maintained there, those recordsare not covered by the Assurance; they are subject to thelimits of any coverage afforded by state or local law. Theconsent form should try to explain how this works. Belowis an example of how this can be done in a fairly straight-forward fashion, bypassing details. The alternativepassage which follows is a more comprehensiveexplanation, variations of which are found in several CDCconsent forms.

[Short Version]“Your test results at CDC are kept private by anAssurance of Confidentiality under the PublicHealth Service Act [Section 308(d)]. This means thatCDC may not let those out with information thatidentifies you for any reason unless you agree. Therecords of what we discuss in the survey will be kept


here in Tampa. We will keep them private to theextent allow by state law.”

[Long Version]“CDC is that part of the U.S. Public Health Servicethat collects the nation’s data on HIV and AIDS. The data that come to CDC are reports of personswhose doctors diagnose them with AIDS or suspectthey have AIDS. CDC uses the data to countnumbers of cases of HIV/AIDS, and to conductstudies of who gets HIV/AIDS and how. Nobody isever named. State and local public health people usethe data to help learn about HIV/AIDS and controlits spread.

Any HIV/AIDS data that come to CDC through thissystem that may identify a person in any way, will bekept private. This is assured under section 308(d) ofthe Public Health Service Act (42 U.S.C. 242K and242m(d)). As a rule, CDC does not get reports whichinclude a person’s full name, address, or phonenumber. Instead, CDC gets data which are taggedwith a code. This code is made from letters andnumbers based on a person’s last name. In the rareevent that CDC does receive your name, CDC canonly release the data with your name if you give yourwritten consent for the purpose. Sometimes, CDCneeds to confirm the data in reports or to alertdoctors or public health people of data in the reports. Each time, CDC will only disclose the minimumamount of facts about you needed to get that done. Your name will not be given. Data kept by state andlocal public health people are held private as allowedby state and local law.

The Director of CDC approves research projectsabout HIV/AIDS only under strict conditions thatkeep private any facts about people. If a researchperson outside of CDC needs HIV/AIDS facts whichcould identify a person, that research person mustsign a certificate. In this, he or she vows to keep alldata private and to disclose nothing about a personwithout the person’s written consent. This vow hasthe force of U.S. law.


COST/PAYMENT Common Situations

COST/PAYMENTWho Pays for VariousProcedures

CDC is not allowed to disclose any HIV/AIDS datathat may identify a person without their writtenconsent to anyone for any non public-health reason. This means that CDC may not disclose these data tothe public, to parties in any lawsuit or court case, orto private companies, such as insurance companiesor employers.”

COST/PAYMENT - Common SituationsBeyond what its title indicates, this section needs to coverthree important financial aspects of a research project. Theseare:

1. Who Pays for Various Procedures - This section needs toclarify who covers the expense of various procedures, e.g.,examinations, tests, vaccines, or therapies that theprospective participant would receive by joining the study. In most cases, the study would cover these costs, and theprospective participant needs to know that. Suggestedreadable wording akin to that which the IRB has approvedin CDC consent forms includes:

“The only cost to you for being in our study isthe time you must spend and what it costs you toget here today.”

2. Payment to Participate - CDC studies commonly paypersons for being part of the research (with money, giftcertificates, etc.). It is acceptable in CDC consent formsto describe payment as reimbursement for their time,trouble or inconvenience, discomfort, and out-of-pocketexpenses for being in the study. It is not acceptable todescribe payment so it may be read as the purchase of aperson’s participation in research, which may be viewed ascoercion. However, the IRB recognizes that on occasionthe amount may be much higher than normal (e.g., $250 -$350 for leukapheresis) to meet market prices or toacknowledge the relative risk and/or discomfort of aparticular clinical procedure. Ideally, that issue isaddressed in this section, but is also appropriate in theProcedures section within the context of what is requiredof a participant. It should never appear in the Benefitssection, because that sends a wrong message. Suggestedreadable wording akin to that which the IRB has approved


COST/PAYMENTPayment to Participate

COST/PAYMENT Less Common Situations

in CDC consent forms include:

“We will give you $25 to repay you for the time youmust take and any costs to you for being in our study. We will give you this $25 if you complete the study,or if you choose to drop out before it ends.”

*****

“After your focus group, we will give you $20. Thisis to help repay you for the time you spent with usand the cost of coming to be in our study. We willgive you this whether you finish the focus group ordecide to withdraw before it ends.”

COST/PAYMENT - Less Common Situations - When anyof the following less common situations arise, they must beadequately addressed in the consent form.

1. Who Pays when Research Merges with Care - Onoccasion, a research project will be conducted as part of amedical procedure for which the participant wouldnormally pay, or a research procedure (e.g., examinationor test) may indicate the need for further diagnostic work-up or curative therapy. Your consent form must explainwho pays for what pieces of this continuum. Suggestedreadable wording akin to that which the IRB has approvedin CDC consent forms includes:

“The test we do for this study will be done at no costto you. But if the test shows that you may have thishealth problem, you will need to pay for seeing yourdoctor. You should also plan to pay for a test toconfirm if you have it. If so, you will also pay for thecost of the drugs to treat it.”

2. Payment Tied to Completion - Typically, payment is nottied to the completion of participation in the study in orderto avoid the appearance of a penalty for withdrawing fromthe research. However, a study’s success can dependheavily on participants finishing the research process. These studies usually involve a narrowly defined cohort


COST/PAYMENTWho Pays when ResearchMerges with Care

COST/PAYMENTPayment Tied toCompletion

and multiple steps, such as serial blood testing, repeatedquestionnaires, or before-and-after testing of some typesurrounding an expensive or critical intervention.

To emphasize the importance of completing the study, youmay want to break payments into segments, with the valueincreasing for each succeeding segment of research. Explain this system to prospective participants byindicating that the higher payments recognize a larger timecommitment necessitated by participating in successivephases in the study. However, do not overtly characterizeany payment as a “bonus” for completion. In order tomake the point about the importance of completing theresearch process, the investigator must:

(a) be completely clear in the Procedures section of theconsent that each participant’s completion is critical tothe research and that individuals should reconsiderjoining the study if they do not now believe they cancomplete it. For example,

“This study will not succeed unless we haveenough people who see it through from start tofinish. Thus, we ask you to join the study only ifyou think that you may be able to do that.”

(b) break up the payment into increments linked to stepsin the research process, so that the payment schedulecan be explained in the Costs/Compensation sectionwithin the context of the need for completion. Forexample:

“We will give you $25 for today’s visit to pay foryour time and costs. Since each visit after thatadds to the time you must give us, we will add $5to that payment each time. Thus, we will begiving you $40 for the last visit when youcomplete the study. We have told you why weneed you to complete the study, but we knowpeople may drop out. If you decide to drop outof the study, we will only repay you for your timeup to the last visit you made.”

(c) make it clear in the Right to Withdraw section that the


COST/PAYMENTNo Share in CommercialResults of Research

sacrifice of repayment for withdrawing early is quiteapart from any rights or benefits they have and willcontinue to enjoy regardless of their decision. Forexample:

“While we hope that you will stay to the end, youare free to drop out of this study at any time. Ifyou do, you will not get any more payments suchas those you got when you were in the study. But you will still be able to get all the care thatyou got before; you will still get the same servicethat you came to expect from us apart frombeing in the study.”

3. No Share in Commercial Results of Research - Onoccasion, CDC studies will contain a possibility that theresearch could result in the development of patentableproducts with commercial application and value. Themost familiar example today is the immortalization ofunique cell lines as the result of some type of geneticresearch. The CDC Office of General Council recentlycollaborated with the IRB to craft easy-to-read language tobe used whenever a study has the potential of producing amarketable product with any commercial value. Thatwording is:

"Your sample may be used in our research to helpour researchers invent or find something new. Theaim is to use the findings and inventions to developnew products that may improve the public health. Attimes, such findings or inventions may have a valueif they are made and sold. The government or itsresearch partners may get a patent on these. Theymay also license these. You would not share in anymoney or other things that the government or anycompany might get for what someone may invent orfind using your study samples. We have no reason tobelieve your samples will be used to invent or findsomething new, but we want you to know what willhappen in case it does."

COMPENSATION The only use of the term “compensation” in the federalregulations refers to money made available to injured research


COMPENSATION

COMPENSATIONNo Compensation Provisionfor Injury

participants to compensate them for disability, etc. Investigator often will use this interchangeably withreimbursement (or “Payment” as used in this referencedocument) which is to cover a participant’s out-of-pocketexpenses for being in a study. As to the issue ofcompensation for injury, the federal regulations requires it beaddressed in the consent from when a study involves morethan minimal risk. No Compensation Provision for Injury - When a studyinvolves more than minimal risk, CDC requires a notificationin the consent form about compensation for injury. Thisstatement should indicate that CDC has made no provision topay for needed care or for restitution should a person beinjured through participation in the study. This does notpreclude an injured participant from taking legal action toseek redress. It only makes it clear that prospectiveparticipants should not expect CDC to step forward withfinancial help or to pay their losses if something goes wrong. Suggested readable wording akin to that which the IRB hasapproved in CDC consent forms include:

“Neither University Hospital nor CDC has set asidefunds to pay you if a mishap occurs. If you are harmedas a result of this project, we will give you emergencyhealth care. You should not expect to receive otherpayment, and we will bill you or your insurer in theusual manner.”

*****

“Doctors at the Clinic will arrange care for any physicalharm that happens from being in the study. But neitherEmory University nor CDC has funds set aside to payyou for costs from being hurt.”

RIGHT TO REFUSE OR WITHDRAW - CommonSituationsEach person recruited for a CDC study has the right to refuseto participate. In addition, each participant in every CDCstudy has the right to withdraw, at any time and for anyreason. In either case, the decision should involve no loss orsacrifice of services to which the person has a right to expectto receive.


RIGHT TO REFUSE ORWITHDRAW - CommonSituations

RIGHT TO REFUSE ORWITHDRAW - Refusal/Withdrawal Rights

Refusal/Withdrawal Rights - Note that this referencedocument calls for citing the first of these assurances in theProcedures section. Given the importance of this message, itis worth repeating here, in a separate section. It is critical thatthis section be written in a way that prospective participantscan understand easily. For example,

“As we said before, you are free to join the study ornot. If you do not join, you will not lose any healthcare service that you expect to get apart from thisstudy. If you decide to join the study, you are alsofree to drop out later for any reason. In that casetoo, you will not lose any health care service that youmay expect apart from this study.”

*****

“You are free to join the study or to decide not tojoin. You may also leave the study at any time, forany reason. If you decide not to join, or to drop outlater, you will lose no health care that you mayexpect apart from this study.”

RIGHT TO REFUSE OR WITHDRAW - Less CommonSituationsSome studies may involve important consequences ofwithdrawal which may not be apparent to a prospectiveparticipant. These studies may involve a more complicatedprocess of withdrawal than simply not showing up. Whenthere are consequences of withdrawing or when there is a needand procedure for an orderly withdrawal, these aspects shouldbe addressed in the consent form. In addition, when the studymay include an investigator’s decision that certain participantsmay lose their eligibility to continue, prospective participantsneed to know that staying in or dropping out is not necessarilytheir choice alone.

1. Consequences of Withdrawal - A participant is free towithdraw, at any time and for any reason. However, in theinterest of informed consent, the investigator must explainthe consequences of a participant's decision to withdrawfrom the study. Sometimes the circumstances of the studycan present a serious challenge to balance the need forcandor with the need to avoid coercing study participants.


RIGHT TO REFUSE ORWITHDRAW Less Common Situations

RIGHT TO REFUSE ORWITHDRAWWithdrawal Consequences

RIGHT TO REFUSE ORWITHDRAWOrderly Withdrawal

For example,

“As we said, you have the right to drop out. But youshould know that the study may not reach its goal iftoo many people drop out. Those whom we asked tojoin are a small number who have been exposed tothis chemical.”

2. Orderly Withdrawal - The investigator also needs toexplain the procedures for an orderly withdrawal. Extending from the example language above, suggestedreadable wording akin to that which the IRB has approvedin CDC consent forms includes:

“Also, we need to know if you do not show upbecause you are ill or because you dropped out. So,if you decide to drop out, please tell a member of thestudy staff before you do.”

3. Withdrawal by Study Staff - The circumstances in some

CDC studies may involve a real possibility that aparticipant's further involvement may be terminated bystudy staff without regard to the participant's consent. When that possibility exists the consent form needs toexplain circumstances under which this may happen. Suggested readable wording akin to that which the IRBhas approved in CDC consent forms includes:

“We told you that you are free to drop out of thestudy at any time and for any reason. You alsoshould know that the study staff could end your partin the study. This may happen if you miss one visitand your return is not within 3 days of that date. You will be dropped from the study if you miss twovisits in a row. This is because the drugs you aretaking in this study need to be given on or near theset visit dates. If not, our study will not be able to usethe results of your blood tests. Staying in the studyafter that would be of no value to us or to you.”

STORAGE OF SPECIMENS FOR FUTURE TESTING -Common Situations The Procedures section covered the storage of specimens forfuture testing when the samples were to be made irrevocably


RIGHT TO REFUSE ORWITHDRAWWithdrawal by Study Staff

SPECIMEN STORAGE Common Situations

SPECIMEN STORAGEComponents of StorageConsent for IdentifiableSpecimens

anonymous. The decision to store “identifiable specimens” -this is, specimens stored in such a way that they could belinked to the donor, involves several issues. It is best toaddress them in a separate section of the consent form. 1. Components of Storage Consent for Identifiable

Specimens When identifiable specimens are to be storedin a CDC study, several possible components must beweighed as part of the consent form for collecting them. How these components are addressed in the consent formdepends upon the clarity of the plans for future testing. The amount of information required in a consent form isproportional to the obscurity of those future testing plans. These components, along with the various possibilities forfuture testing, are presented below. Along with them issuggested wording akin to that which the IRB hasapproved in CDC consents related to stored identifiablespecimens:

a. Explicit Plans for Future Testing - Future plans fortesting stored identifiable specimens are usually theclearest whenever that testing directly relates to thestudy through which they were collected. In this case,the investigator’s explanation is straightforward, andindicates that test results of any health significance willbe returned. For example:

“We plan to test your stored samples when wehave new methods for finding antibody tomeasles. If any test results seem to have meaningfor your health, we will inform you or yourdoctor, as you direct.”

Under these circumstances, you may want to explain

other future tests you anticipate. For example:

“We plan to test your stored samples when we havenew methods for finding antibody to measles. Theonly other testing we might do on your sample is tocheck your immune status to other childhooddiseases. If any test results seem to have meaning foryour health, we will inform you or your doctor, as youdirect.”


SPECIMEN STORAGEExplicit Plans for FutureTesting

You may also wish to specify any sensitive types oftesting that will not be done in order to improveacceptance. For example:

“We plan to test your stored samples when wehave new methods for finding antibody tomeasles. The only other testing we might do onyour sample is to check your immune status toother childhood diseases. If any test results seemto have meaning for your health, we will informyou or your doctor. We plan to do no genetictesting on your sample.”

b. Unclear Plans for Future Testing - Storage with CDCstudies, even of identifiable specimens, most often isfor unspecified future research purposes. The value ofsuch specimens is enhanced by the ability to link themwith other clinical and epidemiologic data on thedonor. However, the inability to be specific forces aninvestigator to cover a range of contingencies, e.g..

“We ask you to agree to freeze part of your bloodand other fluid samples at CDC. We will usethese samples for research in the future. We arenot sure what studies might be done. But if anytest results seem to have meaning for your health,we will inform you or your doctor, as you direct. Some tests we do may be experimental and haveno clear meaning to your health. In those cases,we will not report any results to you or yourdoctor. We will not test your samples for HIV orother STDs. Also, we do not plan to do anygenetic testing on your samples.”

c. When Genetic Testing is Possible - CDC is expandingits genetic testing capabilities to study potential linkswith diseases. Hence, it may be prudent to use thesetests with a sample of stored specimens and toanticipate this need when they are collected with noclearly bounded future purpose. However, testing toidentify a genetic predisposition to disease is differentfrom most other forms of biomedical testing in itspossible benefits and in its potential risks. Therefore,


SPECIMEN STORAGEUnclear Plans for FutureTesting

SPECIMEN STORAGEWhen Genetic Testing isPossible

any possibility of genetic testing on identifiable storedspecimens needs to be preceded by a specific consentto do this testing or a reconsent that would fullyexplain the implications, e.g.,

“At some time we might ask to test your child’sstored sample for a health problem that mayaffect him in the future or which may run in yourfamily. If so, we will tell you what that couldmean and we would only test if you agree to it.”

*****

“We may want to test your stored tissue sample tolook at your genes. We would do this to see if youare more likely than many other people to get adisease. If that happens, we will come to you firstto explain that testing and what it could mean. We will go ahead only if you agree.”

d. The Right to Exclude Certain Testing - When the

storage of identifiable specimens is for uncertain futureresearch purposes, prospective participants should begiven the right to identify any testing which they wantexcluded from research. But because a prospectiveparticipant is unlikely to know the range of possibleresearch testing which CDC may do, it is appropriate tocite some of the more sensitive types. For example:

“You may exclude your stored sample fromcertain types of tests that could be done duringfuture research. Examples include genetic testingto see if a disease may run in your family. Itcould also include testing for HIV (the viruscausing AIDS) or for other STDs. Please note inthe space we provide any types of tests CDCshould not do on your stored sample.”

e. The Right to Refuse/Withdraw - The right to refuse toenroll in research, or to withdraw from a project onceenrolled-both without penalty-are required componentsof informed consent. Future research involving storedidentifiable specimens nearly always is a projectseparate from the study in which the specimens are


SPECIMEN STORAGEThe Right to ExcludeCertain Testing

SPECIMEN STORAGEThe Right to Refuse/Withdraw

collected. When that is the case, the consent formneeds to state those withdrawal rights. In addition, theprocedure for withdrawal from specimen storage willbe quite different from withdrawal from the sourcestudy. Therefore, the statement of this particular rightneeds to include directions as to how to go aboutwithdrawing from storage. For example:

“You may choose not to have your sample storedfor future research and still be part of this study. Also, you may agree to have your sample storedand later decide that you want to withdraw it fromstorage. If so, you should call the study personlisted in this consent form and tell her to discardyour sample. The sample will be discarded as youinstruct. But any data from testing your sampleuntil that point will remain part of the research.”

ALTERNATIVES (if appropriate)The required elements of informed consent include thedisclosure of appropriate alternative procedures or courses oftreatment, if any, that might benefit the prospectiveparticipant.

1. Specifying Alternatives - Many CDC protocols involveproviding diagnostic procedures, therapies, or vaccines. For protocols where this does not apply, there is no needto include a section on alternatives. However, when thisdoes apply, an investigator must inform the prospectiveparticipant of what is available. Examples of readablewording akin to that which the IRB has approved in CDCconsents regarding alternatives include:

“If you do not want to be in the study, you will receivethe standard TB treatment given by the BotswanaNational TB Program.”

*****

“If you do not wish to join this program, we will giveyou care using the regular methods we have alreadyexplained.”

*****


ALTERNATIVE S

ALTERNATIVESSpecifying Alternatives

“You may choose not to be in his study. If so, yourchild’s care will not be affected in any way, now or inthe future. You can get MMR vaccine from yourdoctor or local health department.”

*****

“If you do not wish to join this amended part of theTLC Study, you can get a blood-lead test throughyour doctor for any of your children who got thetainted vitamins.”

PERSONS TO CONTACTThis section discusses two elements that are common tonearly every consent form.

1. Study contact - List the name of the study person tocontact with questions about participation, or concerninginjury sustained as the result of participation. Also,include instructions about how to make that contact. Thissection is likely to contain several $3 syllable propernouns; thus, it is important to try to minimize those wherethe options exists to do so. Suggested readable wordingakin to that which the IRB has approved in CDC consentforms includes:

“If you have any questions about how the studyworks, contact..., the chief study person, at ...”

2. Contact for Participant Rights - The consent should alsoprovide the name of someone to contact with questionsabout the person’s rights as a research participant. Thisshould be someone who is not part of the study, i.e.,responsible for the ethical conduct of research, such as alocal IRB chairperson, the CDC Deputy AssociateDirector for Science, or the CIO Human Subjects Contact. This can be noted by continuing the sample wordingabove with the following:

“If you have any concerns about your rights in thestudy, contact ..., head of the University HumanInvestigations Committee, at ...”

3. Contact in case of injury - The consent should also provide


PERSONS TO CONTACT

PERSONS TO CONTACTStudy Contact

PERSONS TO CONTACTContact for ParticipantRights

PERSONS TO CONTACTContact in Case of Injury

the name of someone to contact in case the participantsustains an injury as a result of the research. This can beeither the contact to answer study question (e.g., thePrincipal Investigator), the contact for questions about theperson’s rights as a study participant, or someone else alltogether. Usually that is the Principal Investigator. Thefollowing is sample wording to cover that:

“If you think that you have been injured by beingin this study, contact..., the chief study person,at...”

YOUR CONSENT In this section of the consent form, prospective participantsare asked to declare whether they will enroll in the study. This statement can be written in two different ways.

1. An “I” Construct Statement - The most common approachis to write an “I” construct declarative statement, whichbasically puts words in the mouth of the prospectiveparticipants about everything that is understood. It alsosays that an opportunity has been given to have allquestions answered to the individual's satisfaction. Usecare if you use this construct because its tone can be veryformal and it can invite the use of complex sentencestructures and polysyllabic words. The examples belowillustrate how to use the “I” construct and easy-to-understand language akin to what the CDC has approvedin consent forms:

“I agree to be in this study. I have been given achance to ask questions and I feel that all of myquestions have been answered. I know that being inthis study is my choice. I know that after choosing tobe in this study, I may leave it at any time. I knowthat if I wish to leave the study at any time, I maycontact ...at...”

*****

“I have read this consent form. I have had myquestions answered so that all parts of the study areclear to me now. I have received a copy of thisconsent form. I agree to my child being a part of this


YOUR CONSENT

YOUR CONSENTAn “I” Construct Statement

YOUR CONSENTA Construct Addressing theProspective Participant

study.”

2. A Construct Addressing the Prospective Participant - Werecommend addressing the prospective participant ratherthan using the “I” construct. This format may to be easierto understand and has a more informal tone. This is theonly practical format to use in preparing an oral consentscript. An example of easy-to-read wording akin to thatwhich the IRB has approved in CDC consent formincludes:

“We have given you a copy of the consent form. When you sign below, it shows that you agree to letyour child be part of the study. If there is any part ofthis form which is unclear to you, be sure to askquestions about it. Do not sign until you get solidanswers to all of your questions. When you are readyto let your child be part of the study, sign your nameon the line below.”

SIGNATURE LINES, APPROVAL BOXES, WITNESSSIGNATURE LINES, DESIGNATIONS, AND REFUSALThe end of the consent form involves some conventions whichan investigator needs to observe. These include thepositioning of signature lines, using “check-off” boxes tosignify special approvals, allowing for designations,explaining what witnesses are witnessing, and the issue ofindicating refusal to participate.

1. Signature Line Position - The signature line for theprospective participant to enroll in the study should bepositioned after any special “check-off” boxes, such as forstorage. This is to reinforce the concept that a prospectiveparticipant can disagree to future testing and still take partin the present study.

2. Approval Boxes - Many CDC studies involve procedures,such as specimen storage or identifying who should gettest results, which call for separate specific consents. Using separate signature lines can be confusing. Theclearest, most efficient way to obtain such special consentsis to provide “check-off” boxes. For example:


SIGNATURES LINES, etc.

SIGNATURES LINES, etc.Signature Line Position

SIGNATURES LINES, etc.Approval Boxes

“Please Check One Box

� I give consent for my blood to be stored at CDC

under the conditions outlined in this consentform.

� I DO NOT give consent for my blood to be

stored at CDC for future research.”

3. Witness Signature Line - CDC consent forms sometimesinclude a witness signature line. If a witness is required,craft language for that signature line to describe what theperson will witness. This can be from just witnessing theprospective participant’s signature to observing the entireconsent process, including the signature. The statementaccompanying the witness signature line should reflectthe witness’ role; it should also be realistic. For example,it should not say “I confirm that the prospectiveparticipant completely understood the consent form andgot satisfactory answers to all of his/her questions.” More realistic wording might be:

“I observed the process of consent. The prospectiveparticipant read this form, was given the chance toask questions, appeared to accept the answers, andsigned to enroll in the study.”

4. Designations - When a protocol involves current or future

testing with participant identifiers, the participant shouldbe given the right to designate the routing of the results ofthose clinical tests. There are exceptions where the testsare experimental, in which case results will not bereturned. However, prospective participants areexplicitly informed of this in the consent. Also, theremay be tests about which the investigators justly feeluncomfortable having results going to the participantrather than a physician who can interpret them andexplain their implications. The consent form should beexplicit about this as well when it applies. Otherwise, theconsent form should give the prospective participant theoption to designate if results should be sent to them or totheir doctor. Space should be devoted to designating thephysician’s name and address in the event that option isselected, e.g.,


Note: Do not include a line for noting refusal to participate or for a reason forthat refusal. Both measures are inherently coercive and inappropriate.

SIGNATURES LINES, etc.Witness Signature Line

SIGNATURE LINES, etc.Designations

“Please give any facts about my health ( ) directly tome or ( ) directly to my doctor (address below).”


SIGNATURES LINES, etc.Refusal

54

Appendix A

2 Developed by Harold C. McGraw, Office of Educational Research, Baltimore CountySchools, Towson, MD.

3 Doak, Cecilia C., Leonard G. Doak, and Jane H. Root (1995). Teaching Patients with LowLiteracy Skills. New York: J.B. Lippincott Co. 36-59.

4 Ibid: page 59 cites a 1979-81 test of the method conducted by Patient Learning Associates,Inc., of Potomac, Maryland, in which the SMOG formula performed exceptionally whenused to grade materials presented to 291 individuals graded by accepted methods as havingreading levels between the 4th and 16th grades.

55

SMOGReadability Formula

The SMOG2 formula is a recommended3 and tested4 method for grading the readability of writtenmaterials. The method is quick, simple to use and particularly useful for shorter materials, e.g., astudy’s information pamphlet or consent form. To calculate the SMOG reading level, begin withthe entire written work being assessed and follow these steps:

1. Count off 10 consecutive sentences near the beginning, in the middle, and near the end of thetext. If the text has fewer than 30 sentences, use as many as are provided.

2. Count the number of words containing 3 or more syllables (polysyllabic), including repetitionsof the same word.

3. Look up the approximate grade level on the SMOG conversion table below:

Total P olysyllab ic Approximate Grade Level

Word Count (±1.5 Grade s)

1-6 5

7-12 6

13-20 7

21-30 8

31-42 9

43-56 10

57-72 11

73-90 12

91-110 13

111-132 14

133-156 15

157-182 16

183-210 17

211-240 18

When using the SMOG formula:o A sentence is defined as a string of words punctuated with a period, an exclamation mark, or

a question mark. Consider long sentences with a semi-colon as two sentences.


2

o Hyphenated words are considered as one word.

o Numbers which are written should be counted. If written in numeric form, they should bepronounced to determine if they are polysyllabic.

o Proper nouns, if polysyllabic, should be counted.

o Abbreviations should be read as though unabbreviated to determine if they are polysyllabic. However, abbreviations should be avoided unless commonly known.

o If the written piece being graded is shorter than 30 sentences, approach it as follows:-- Count all of the polysyllabic words in the test.-- Count the number of sentences.-- Find the average number of polysyllabic words per sentence, i.e.:

Total # of polysyllabic words Average = Total # of sentences

-- Multiply that average by the average number of sentences short of 30.-- Add that figure on to the total number of polysyllabic words.-- Compare the number of polysyllabic words in the SMOG conversion table.

SPANISH READABILITY FORMULAS

Crawford, A.N. (March 1984). A Spanish language Fry type readability procedure: Elementary level. Los Angeles: Bilingual Education Paper Series, Evaluation Dissemination and Assessment Center,California State University, Los Angeles, 7:1-17.

Garcia, W.F. (1976). Assessing readability for Spanish as a second language: The Fry graph and clozeprocedure. Unpublished doctoral dissertation, Teachers College, Columbia University.

Gilliam, B., Pena, S.C., and Mountain, L. (1980). “The Fry graph applied to Spanish readability.” TheReading Teacher, 33:426-430.

Spaulding, S. (1956). “A Spanish Readability formula.” The Modern Language Journal. 40:433-441.

Spaulding, S. (1951). “Two formulas for estimating the reading difficulty of Spanish.” EducationalResearch Bulletin, 30:117-124

Acknowledgment

Thanks to Dr. Mary S. Neumann, DHAP, NCHSTP, for her research of SMOG and her assistancebased on her wide use of the method to improve the readability of materials produced by CDC orthrough CDC grant support. Thanks also for her research of the Spanish language formulaswhich appear in the guide “Developing Effective Educational Print Materials” which she authoredwith the TEB, DSTDP, NCHSTP.


The Fry Readability Scale

Directions:! Select three 100-word passages from the beginning, end, and approximate middle of

the consent form.! Count proper nouns, numerals, and initializations as words.! Count the number of syllables, counting each symbol in numerals and initializations as

one syllable, e.g., 1997 as 1 word and 4 syllables; CDC as 1 word and 3 syllables. Asuggested easy way to count is to put a mark above every syllable beyond 1 in eachword, count the number of marks, and add 100.

! Count the number of sentences in each 100 words, estimating the length of the fractionof the last sentence to the nearest 1/10th.

! Add the number of sentences and the number of syllables and divide each total by 3.! On the Fry Graph below, find the average number of sentences on the side scale and

find the average number of sentences on the top scale. Where the points meet indicatesthe approximate reading level grade of the form.

58

Appendix B

59

Easy-to-Read Replacement Words/Phrases for Polysyllabic Terms Common to CDC Consent Forms

Common Polysyllabic Possible ReplacementTerms in CDC Consents Words/PhrasesAdditional information about Other facts about/more facts aboutAllowing LettingAnother Any other/More/One moreBlood will be collected We will take blood By agreeing If you agreeBy telephone By phoneComparison group A group used to compare resultsCommonly Most oftenCompensate RepayConfidential/Sensitive PrivateConsider Think aboutContinue/Continued Go on/Keep on going/Kept on goingContracting GettingConvenient HandyCurrently receiving Now gettingDecision ChoiceDeleted ErasedDescription A statement which describesDetermine whether Learn ifDeveloped Put in placeDirectly In a direct wayDiscomfort Worry/woe/aches/sorenessDiscover/discovered Find/foundDizziness Feeling dizzyEducational background Level of schoolingEnrolling Joining/being inEntitled to otherwise Have a right to receive apart from thisEspecially MainlyEvidence of Signs of/proof ofExplanation A statement which explainsExposure to Risk of getting/being exposed toFor example For instanceFor study purposes To carry out the studyGeneral/generalized Wide spreadHowever But/yetImplemented Put in placeIn addition AlsoIncluding Along withInfected with the... Having/with the...Information FactsInjury HarmInoculation/injection ShotInterested in... Would like to know about...In this community Around hereMake it possible to.. Allow us to...Medical record Health record

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Easy-to-Read Replacement Words/Phrases for Polysyllabic Terms Common to CDC Consent Forms

(Continued)

Common Polysyllabic Possible ReplacementTerms in CDC Consents Words/PhrasesMonitor Check onNausea Upset stomach/feeling queasyNegligible SmallParticipate/participating Be in/being inParticipation in... Being part of... Permitted AllowedPersonal Your ownPhysician Doctor Pregnancy, during When you are pregnantPregnancy outcomes Birth outcomesPrevious studies Studies done beforePreviously unrecognized virus/ Virus we did not know about recently discovered... before nowProtected Kept privateProvide explanations for Explain whyProvided/providing Given/givingQuestionnaire Survey formRamifications Problems/results/outcomesReceiving GettingRegulations RulesRelevant Tied in withRequested Asked forResearchers/Scientists People doing the studyResulted Came fromSatisfactory OK/fineSchedule an appointment Set a timeSeveral Some/a few/a number ofSpecimens SamplesSexual behaviors Types of sexSexually transmitted diseases VD or (STDs)Study coordinator The person who leads the

studySubstantial Large/bigSuggested Pointed toThank you for volunteering to be in... Thank you, we are glad that

you agreed to be in...The information we collect What you tell usTo the extent legally permissible To the extent allowed by lawTransmitted Passed on to other peopleUnderstand Learn/seeVomiting Throwing upYour understanding of ... What you know about...

CONSENT FOR CDC RESEARCH

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